EasyCDM Suiterobust discrepancy management system allows for both
- Auto edit checks – where Automated discrepancies are generated for Data values out of range, and.
- Manual Edit checks – where ad-hoc discrepancies can be raised by Sponsor/Monitor about any data element in the CRF.
The system also highlights discrepancies and permits the PI/Discrepancy Manager to offer resolutions.
Validation of an edit check is the official process of demonstrating that an edit check works correctly with the expected level of quality.
When an electronic CRF is in use data entry is carried out at the investigative site where the clinical trial is conducted by site staff who have been granted appropriate access to do so.
When using a paper CRF the pages are entered by data entry operators. Best practice is for a first pass data entry to be completed followed by a second pass or verification step by an independent operator.
Edit checks are programmable validations which are used by Data Management to clean data throughout a clinical trial which, in turn, helps ensure accuracy. These edit checks, like any other programming; can be flawed for a number of reasons including programming error or misinterpretation of the specification.